Coaxial micro-endoscope

ABSTRACT

A deflectable endoscope including an imaging structure, an outer member having a proximal portion and a distal portion, an elongated column member extending distally from the outer member and an inner member positioned coaxial with the outer member and attached to the column member. The inner member extends distally of the outer member and has a distal tip portion. A reinforcement member is positioned over the column member to restrict axial movement of the column member such that when one of the inner member or outer member is moved with respect to the other, axial compression of the column member is restricted by the reinforcement member causing the distal tip portion of the inner member to deflect laterally.

BACKGROUND

This application is a continuation of application Ser. No. 14/064,171,filed Oct. 27, 2013, which claims priority from provisional application61/724,922, filed Nov. 10, 2012, the entire contents of which areincorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to medical devices, and inparticular medical catheters with optical capabilities and/or steeringcapabilities.

BACKGROUND OF RELATED ART

An endoscope is an illuminated usually fiber-optic flexible or rigidtubular instrument for providing direct visualization to the interior ofa hollow organ or part (as the bladder or esophagus) for diagnostic ortherapeutic purposes that typically has one or more channels to enablepassage of instruments (as forceps or scissors). The scope is insertedthrough a natural opening, such as the mouth during a bronchoscopy orthe rectum for a sigmoidoscopy.

Because current endoscopes have outer shaft diameters of approximately 5mm or greater, they typically can only be used in relatively large bodylumens. As a consequence, they can only provide direct visualization tothe large lumen and the entrance to the small lumens that branch off. Inorder to examine a small lumen further, i.e., beyond the entrance, acatheter has to be inserted through the working channel of the endoscopeand then passed down into the small lumen. Visualization is then donethrough radiographical means.

A variety of attempts have been made to provide catheters capable ofnavigating into small lumens to provide direct visualization andtreatment. For example, U.S. Pat. No. 7,922,650 to McWeeney et al.discloses a direct visualization system that includes a reusable opticalassembly and a disposable co-linear multi-lumen, steerable catheter thatcan be tracked over a guidewire. The catheter, which has a 10 French(3.3 mm) outer diameter, has one working channel, two irrigationchannels, and a dedicated optical assembly lumen. The optical assembly,which has a diameter of approximately 0.77 mm is made of a fiber opticbundle surrounded by lights. Because the optical assembly is free of thecatheter and has a small crossing profile it is able to enter normalbile and pancreatic ducts, which have diameters as small as 2 to 3 mm.However, the catheter itself, with a 3.3 mm crossing profile, is stillrestricted access. As a result, visualization which starts out moderateat best due to use of fiber optics is further impaired by any stonedebris or sludge that cannot be properly flushed from a distance. Inaddition, the optical assembly is fragile and must be handled with care.

U.S. Pat. No. 7,922,654 to Boutillette et al. discloses a small diametersteerable imaging catheter with at least one steering cable extendingalong the catheter tube to control movement of the distal end and afiber optic cable extending along the catheter tube. The catheter tubeis constructed to have greater flexibility near its distal end portionwhile having greater stiffness in the remainder of the tube. It alsodiscloses that this may be accomplished by varying durometer ratings ofthe materials used to form the catheter tube. It further discloses thatthis construction concentrates the flexing at the distal end portion,rather than throughout the entire catheter tube, to thereby reduce unduetwisting of the catheter tube along its entire length, and further topermit better control of the movement of the distal end portion. Inorder to provide a smaller diameter steerable imaging catheter, the '654patent provides a shaft with fewer independent channels (lumens) thanthe '650 patent which relies solely on shaft design and steering wires,not a guidewire, for navigation. The lack of independent channelsresults in the sharing of channels that are present. For instance,irrigation or flushing of the fiber optic may be interrupted if acutting wire is needed for cutting out undesirable material.Interruption in flow will result in impaired visualization due to sludgeor debris that cannot be properly flushed from in front of the fiberoptic during the procedure. Also, the '654 patent uses fiber optictechnology in the design due to its small delivery diameter. Like the'650 patent, this creates a fragile device with poor image quality.

Both of the above patents disclose co-linear multi-lumen tubes with atleast one of the lumens dedicated to a fiber optic for viewing. Inaddition, both require the use of push/pull or steering wires, which areplaced circumferentially around the catheter adding to the overall size.

There exists a need for smaller diameter devices with imagingcapability. The need further exists for such smaller diameter devicesthat are highly navigable with an imaging technology that presents highresolution, color images to aid in the diagnosis and treatment of apatient. It would further be beneficial if such devices could bedesigned with deflection without increasing their size to therebymaintain their low profile. It would also be beneficial if such devicescould enable flushing of the imaging devices to aid visualization.

SUMMARY OF INVENTION

The present invention overcomes the problems and deficiencies of theprior art.

The present invention provides in one aspect a deflectable endoscopecomprising an imaging structure, an outer member having a proximalportion and a distal portion, an elongated column member extendingdistally from the outer member, and an inner member positioned coaxialwith the outer member and attached to the column member. The innermember extends distally of the outer member and has a distal tipportion. A reinforcement member is positioned over the column member torestrict axial movement of the column member such that when one of theinner member or outer member is moved with respect to the other, axialcompression of the column member is restricted by the reinforcementmember causing the distal tip portion of the inner member to deflectlaterally.

In some embodiments, the outer member has a central longitudinal axisand the column member is radially offset with respect to the centrallongitudinal axis of the outer member.

In some embodiments, the lateral reinforcement member comprises a tube.In some embodiments, the tube is a helically wound flexible coil. Insome embodiments, the column member is fixedly attached to the outermember and the inner member. In other embodiments, the column member isattached only to the inner member.

The outer member can have a central lumen to receive the inner memberand/or the inner member can have a central lumen to receive a guidewireor other accessory. The central lumen of outer member can be lubricatedto facilitate movement of the inner member therein to facilitatedeflection.

The column member is preferably non-circular in cross section. In someembodiments, the column member has a proximal portion attached to thedistal portion of the outer member and a distal portion attached to thedistal portion of the inner member.

The endoscope can further include a marker band at the distal portion ofthe inner member and the column can be attached to the marker band. Insome embodiments, a proximal portion of the column member terminates ata distal portion of the outer member.

Preferably, upon movement of the inner member proximally or the outermember distally, the axial compression of the column member is limitedby the reinforcement member so it cannot fail axially but instead failslaterally to deflect the distal tip portion.

In some embodiments the endoscope includes first and second marker bandson the inner member, and the column member is attached to the first andsecond marker bands.

A locking assembly can be provided to lock the position of the innermember with respect to the outer member.

The inner member can have a cut tube at its distal end portion toprovide flexibility.

In some embodiments, the imaging structure is attached to the outermember and does not deflect with the distal tip portion. In otherembodiments, the imaging structure is attached to the inner member anddeflects with the distal tip portion. In some embodiments, the imagingstructure includes a complementary metal-oxide-semiconductor module. Alighting structure can be integrated with the imaging structure oralternatively a separate component from the imaging structure.

In accordance with another aspect of the present invention, adeflectable endoscope is provided comprising a proximal portion, anintermediate portion, a deflectable distal tip portion and an imagingdevice. A first movable member is axially movable from a first positionto a second position, wherein the distal tip portion is deflectable byan axial movement of the first member in which the distal tip portioncannot fail axially in compression so it fails laterally causingdeflection of the distal tip portion in a first direction.

In some embodiments, the first movable member is positioned within asecond member, and the first position is distal of the second position.In other embodiments, the first movable member is positioned over asecond movable member and the first position is proximal of the secondposition. In some embodiments, the first movable member deflects whilethe second movable member remains substantially stationary orsubstantially non-deflected. In some embodiments, axial movement in anopposite direction causes a bending of the distal tip portion in theopposite direction.

In some embodiments the imaging device is attached to the outer memberand does not deflect with the distal tip portion. In some embodiments,the imaging device is attached to the inner member and deflects with thedistal tip portion.

The present invention provides in accordance with another aspect adeflectable endoscope having a deflectable distal tip portion comprisingan outer catheter having a lumen, a proximal portion and a distalportion, an elongated member extending distally from the outer member,and an inner catheter positioned coaxially within the inner lumen of theouter catheter and attached to the elongated member, wherein axialmovement of one of the outer member and inner member causes the distaltip portion of the catheter to deflect laterally. An imaging device iscarried by one or both of the inner or outer catheters.

In some embodiments, the elongated member is attached to the innermember and is surrounded by a movement restriction member to restrictaxial movement of the column member when the outer member or innermember is moved axially relative to the other. Preferably, such axialrestriction limits axial compression of the column member upon axialmovement in one direction. In some embodiments, a tip of the innercatheter deflects and a tip of the outer catheter remains substantiallynon-deflected.

Preferably, movement of the inner catheter in one direction causes axialcompression of the elongated member and movement of the inner catheterin a second direction causes bending of the elongated member to causedeflection in a second opposite direction.

In accordance with another aspect of the present invention, adeflectable endoscope is provided having a deflectable distal tipportion. The endoscope includes an imaging device, an outer catheterhaving a lumen, a proximal portion and a distal portion, an innercatheter positioned coaxially within the inner lumen of the outercatheter and having a distal tip portion extending distally of a distalend of the outer catheter, and a column member attached to the innercatheter, wherein axial movement of one of the outer member and innermember acts on the column member to cause the distal tip portion of theinner catheter to deflect laterally.

In some embodiments, the column member includes a proximal stopcontacted by the outer catheter.

In accordance with another aspect of the present invention, amicro-endoscope is provided having an outer member having a proximalportion, a distal portion, an outer surface and an inner surface, and animaging device positioned on an outer surface of the outer member andincluding transmission members extending proximally to the proximalportion of the outer member. In some embodiments, the transmissionmembers extend through a lumen in the outer member. In otherembodiments, the transmission members extend along the outer surface ofthe outer member. In some embodiments the imaging device is mounted at adistal tip of the outer member. In some embodiments the imaging deviceincludes a complementary metal oxide semi-conductor module. In someembodiments, a tubing is positioned over the imaging device and over aleast a portion of the outer surface of the outer member to retain theimaging device on the outer surface.

The present invention also provides in accordance with another aspect adeflectable coaxial catheter comprising an inner catheter, an outercatheter positioned coaxially over the inner catheter wherein relativemovement of the inner and outer catheters deflects a distal tip portionof the coaxial catheter, and an imaging structure carried by one or bothof the inner catheter and outer catheter. In some embodiments, theimaging structure is proximal of the deflecting distal tip portion. Inother embodiments, the imaging structure is attached to the deflectingdistal tip portion.

In some embodiments, the imaging structure is mounted on an outersurface of the outer catheter. In other embodiments, the imagingstructure is attached to an outer surface of the inner member.

The catheter can further comprise a tubing positioned over the imagingstructure to secure the imaging structure to the other surface of thecatheter.

In accordance with another aspect of the present invention, adeflectable endoscope is provided comprising a proximal portion, anintermediate portion, a deflectable distal tip portion and an imagingdevice. The imaging device is axially movable from a first position to asecond position, wherein the distal tip portion is deflectable by anaxial movement of the imaging device in which the distal tip portioncannot fail axially in compression so it fails laterally causingdeflection of the distal tip portion in a first direction. In someembodiments, the imaging device includes as optical fiber. In someembodiments, the imaging device is positioned within an outer member. Insome embodiments, the imaging device includes a data cable.

The present invention also provides in accordance with another aspect acoaxial bi-directional deflectable microendoscope which can belubricated internally through external application to help overcomefriction between the inner catheter and the outer catheter whiledeflecting the distal tip in narrow, tortuous vasculature. In a methodfor lubricating the deflection lumen formed by the inner diameter of theouter catheter, a syringe filled with fluid can be connected to a sidearm. The side arm can be part of a locking assembly, and prior to theprocedure, with the locking assembly in a locked position, fluid can beinjected into the inner lumen of the outer catheter. The lockingassembly can then be opened and the inner catheter pulled and pushed todeflect the tip, with the fluid ensuring smooth movement. With thelocking assembly locked, the catheter and guidewire can then be insertedand tracked through the anatomy. If, at any point, deflection isimpaired, additional lubrication fluid can be introduced through theside arm using a syringe.

The present invention also provides a coaxial micro-endoscope whichovercomes current limitations in diameter, image quality and navigation.The present invention provides in some aspects a coaxial microcatheterwith video visualization technology held in close contact with the outerdiameter of the catheter. In deflectable micro-endoscope embodiments, ituses the inner catheter to bring about bi-directional deflection. Italso can provide irrigation introduced between the catheters tofacilitate relative movement and thus deflection.

The small diameter coaxial micro-endoscope and the small diametercoaxial bi-directional (deflectable) micro-endoscope of the presentinvention can be used as a stand-alone scope or inserted into a largerendoscope as part of a procedure such as examination of biliary orpancreatic ducts. The micro-endoscope is designed to navigate using aguidewire in combination with a deflectable tip. In addition, videotechnology is piggybacked on the micro-endoscope's outer catheter whereit is held in place such as by a highly flexible tube thereby reducingthe need for a dedicated imaging lumen.

Various methods for attaching an imaging or treatment technology to theouter wall of a medical device are provided.

In accordance with one aspect of this invention, a non-deflectablemicro-endoscope is provided, including a microcatheter, a complementarymetal-oxide-semiconductor (CMOS) module (consisting of a lens, CMOSsensor, and flexible printed circuit (FPC) glued inside a protectivehousing), lighting, miniature coaxial cables connecting the CMOS moduleand lighting to a proximal connector, and a polymer heat shrink tube. Inan exemplary construction, the CMOS module and lighting are adhered tothe distal end of the microcatheter and a portion of the miniaturecoaxial cables connected to them is stretched along the exterior of themicrocatheter's substantially useable length towards the catheter'sproximal end. Attachment external to the micro-endoscope reduces theoverall diameter of the micro-endoscope since it does not need internalspace to accommodate the imaging and lighting system. Polymer heatshrink tubing can cover the microcatheter, CMOS module/lighting andcoaxial cables along a portion of the useable length of themicrocatheter. The polymer heat shrink tube serves to keep the miniaturecoaxial cables in close contact with the microcatheter body as well asan outer jacket for the entire assembly. A Rotating Hemostatic Valve(RHV) can be attached to the winged hub (luer) at the proximalmost endof the microcatheter to allow inner lumen access as well as irrigationand/or insufflation at the distal end. The inner lumen of themicrocatheter can serve as the working channel of the micro-endoscopefor passage of guidewires, biopsy forceps, RF cutting wires, fiberoptics, or other accessories needed for carrying out diagnostic ortherapeutic functions. The micro-endoscope's microcatheter body can bedesigned with a variable stiffness shaft for tracking over a guidewire.Hydrophilic coating may be introduced to the outer jacket to help withmovement. The portion of the coaxial cables that are free (not incontact with the catheter body) can also be in a protective jacket madeof either an extrusion or protective shrink tubing. An optional strainrelief can be placed over the proximal end of the catheter where thedistal end of the free miniature coaxial cables covered in extrusion orprotective shrink tubing meet the proximal end of the outer catheter andminiature coaxial cables covered in the polymer heat shrink tube.Preferably, at the very proximal end of the free miniature coaxialcables is a connector. The connector can be used to connect to aninterface board, which mates the micro-endoscope with devices such as avideo processing/display system, computer, tablet (IPad), or smart phonefor viewing and/or recording. The entire micro-endoscope includingconnector can be disposable or, if desired, re-usable with propercleaning.

In accordance with another aspect of the present invention, a coaxialbi-directional (deflectable) micro-endoscope is provided including acoaxial bi-directional microcatheter and an imaging system held in closecontact to the outer catheter with a shrinkable polymer cover. In thepreferred construction, the micro-endoscope described in the previousembodiment will serve as the outer catheter for the coaxialbi-directional micro-endoscope described here. An inner catheter, with alength greater than the useable length of the outer catheter, isslidably disposed through the outer catheter which is provided with animaging system and RHV. The distal end of the inner catheter, whichextends past the distal end of the outer catheter, is configured fordeflection and covered with a flexible helical coil. The proximal end ofthe inner catheter can have an RHV. The inner lumen of the innercatheter of the coaxial bi-directional micro-endoscope can serve as theworking channel for passage of guidewires, forceps, optical biopsydevices or other accessories needed for carrying out diagnostic ortherapeutic functions. Air/gas irrigation and/or insufflation can insome embodiments be introduced through a side arm of the RHV on theproximal end of the outer catheter and can exit the distal end of theouter catheter through holes in the outer shaft or through gaps or holesformed on the deflectable distal tip. In some embodiments, additionalirrigation and/or insufflation can be introduced through the side arm onthe RHV on the proximal end of the inner catheter. The inner lumen ofthe inner catheter also serves to deflect the distal tip. To do this, insome embodiments, the lock (end cap on the RHV) on the proximal end ofthe outer catheter is opened, freeing the inner catheter to move axiallyback and forth causing the distal tip to deflect. Deflection occurs asthe inner catheter is pulled proximally (or the outer catheter is moveddistally), thereby compressing the column at the distal end. When theinner catheter is pushed distally (or the outer catheter is movedproximally), the column will bend causing the distal tip to deflect inthe opposite direction. The coaxial bi-directional micro-endoscope canhave in some embodiments variable stiffness shafts designed to be pushedand tracked over a guidewire. Hydrophilic coating may be introduced onboth the inner catheter and outer catheter to help with movement.

In accordance with another aspect of the present invention, a coaxialbi-directional micro-endoscope is provided including a coaxialbi-directional microcatheter with imaging and lighting positioned on thedeflecting distal tip portion of the micro-endoscope. In someembodiments, the CMOS module and lighting with a portion of the coaxialcables extend past the distal end of the outer catheter of the coaxialbi-directional microcatheter. The CMOS module and lighting can beattached to the distal end of the deflectable tip portion of themicro-endoscope. The attachment orientation can in some embodiments beparallel and in other embodiments perpendicular to deflection. In someembodiments, the miniature coaxial cables running along the exterior ofthe outer catheter of the coaxial micro-endoscope can be held in contactby the polymer shrink tubing, while the distal deflecting tip portionwith CMOS module and lighting can be covered with a more flexible tubesuch as balloon tubing.

In accordance with another aspect of the present invention, a coaxialbi-directional micro-endoscope is provided including a dual lumencoaxial bi-directional microcatheter with an imaging and lightingsystem. In the preferred construction, a second outer catheter is placedparallel to the outer catheter for the coaxial bi-directionalmicrocatheter. The CMOS module and lighting are then adhered to a distalend of the outer catheter and a polymer cover can be shrunk around allthree parts to create the dual lumen outer catheter. The inner catheterand remaining parts can then be added to complete the coaxialbi-directional micro-endoscope. If desired, the distal deflection coilcan cover one or both outer catheters.

In some embodiments, the protective distal housing for the CMOS modulecan be replaced with an adhesive barrier that tapers from distal toproximal.

In accordance with another aspect of the present invention, anon-deflectable coaxial micro-endoscope with a removable inner catheteris provided. In the preferred construction, the inner catheter isslidably disposed through the outer catheter so that their distal endsare flush. As in previous aspects, the CMOS module, lighting, andminiature coaxial cables can be kept in close contact with the outercatheter with a polymer shrink tubing or by other methods. The lumenformed between the inner catheter and the outer catheter can be used forirrigation and/or insufflation, which is introduced through an RHV onthe proximal end of the outer catheter. Accessories can be deliveredthrough the inner lumen of the inner catheter. Should a larger workingchannel be needed, the inner catheter can be removed so that the innerlumen of the outer catheter becomes the working channel for themicro-endoscope.

In accordance with another aspect of the present invention, a coaxialbi-directional micro-endoscope with no working channel is disclosed. Inone construction, the miniature coaxial cables can run through the innerlumen of the inner catheter of the coaxial bi-directionalmicro-endoscope and the CMOS module and lighting are connected to thedistal end of the micro-endoscope. Irrigation and/or insufflation can beintroduced through the side arm on the RI-IV at the proximal end of theouter catheter. Exit holes for irrigation/insufflation can be cut intothe outer shaft or gaps can be introduced in the deflectable tip coil.

In accordance with another aspect of the present invention, a method forthe attachment of an imaging, treatment, or lighting system to acatheter is provided. In one construction, the distal end of theimaging, lighting, or treatment system is adhered to the distal end ofthe medical device and then the fibers or cables are stretched to thedesired length along the exterior of the device and a heat shrink tubingis slid over the assembly. Heat is applied to shrink the tubing down sothat the fibers or cables come in close contact with the exterior of thedevice where they are held in position. The remaining free cables can beencapsulated in another shrink tubing or may come from the factorycovered with a protective extrusion. An optional strain relief can beplaced over the distal end of cables covered by the shrink tubing orextrusion where it meets the proximal end of the shrink tubing coveringthe device/miniature coaxial cables. If the medical device is a ballooncatheter, the image, lighting, or treatment system can be placed on themain catheter body (proximal of the balloon), on the distal tip (distalof the balloon), on a point in between.

The micro-endoscope of the present invention provides in-vivovisualization systems that are suitable for viewing and/or performingdiagnostic and therapeutic modalities in the human body, such as in thebiliary tree.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of one embodiment of a variable stiffnessmicrocatheter;

FIG. 2 illustrates a CMOS module structure having a CMOS module housingand lighting connected to a proximal connector by miniature coaxialcables;

FIG. 3 illustrates the microcatheter of FIG. 1 with the CMOS modulestructure of FIG. 2 attached externally using polymer shrink tubing inaccordance with one embodiment of the present invention;

FIG. 4 is a side view of an alternate embodiment of a microcatheter withCMOS module structure with the distalmost CMOS housing and lighting freeof shrink tubing and mountable to an inner catheter (not shown);

FIG. 5 illustrates a deflectable coaxial bi-directional micro-endoscopein accordance with one embodiment of the present invention whichincludes the outer catheter of FIG. 3 and a first embodiment of an innercatheter;

FIG. 6A is an enlarged top view of the distal portion of the coaxialbi-directional micro-endoscope of FIG. 5 showing tip deflection relativeto CMOS module placement;

FIG. 6B is a side view of the deflection structure of themicro-endoscope shown in the non-deflected position and shown with thelateral reinforcement (support) tube removed for clarity;

FIGS. 6C is a side view similar to FIG. 6B showing deflection of thedistal tip upon retraction of the inner catheter in the absence of thelateral (axial) reinforcement (support) tube;

FIG. 6D is a side view showing deflection of the distal tip in thepresence of the lateral reinforcement tube;

FIG. 6E is a view similar to FIG. 6D showing a portion of thereinforcement tube cut away to show movement of the column;

FIG. 6F is a side view showing deflection of the distal tip uponadvancement of the inner catheter in the absence of the lateralreinforcement tube;

FIG. 6G is a side view showing deflection of the distal tip when theinner catheter is advanced in the presence of the lateral reinforcementtube;

FIG. 6H is a view similar to FIG. 6G showing a portion of thereinforcement tube cut away to show movement of the column;

FIG. 7 illustrates a coaxial bi-directional micro-endoscope inaccordance with another embodiment of the present invention whichincludes the outer catheter of FIG. 4 and the inner catheter of FIG. 5(the CMOS module shown unattached for clarity);

FIG. 8 is an enlarged side view of the distal portion of the coaxialbi-directional micro-endoscope of FIG. 7 with the CMOS housing mountedparallel to deflection and FIG. 9 is an enlarged side view of the distalportion of an alternate embodiment of the coaxial bi-directionalmicro-endoscope with the CMOS housing mounted perpendicular todeflection;

FIG. 10 is an enlarged side view of the distal portion of anotherembodiment of the coaxial bi-directional micro-endoscope with the CMOShousing mounted perpendicular to deflection and having an outer cover;

FIG. 10A is an enlarged front view of the distal tip of the coaxialbi-directional micro-endoscope of FIG. 10 showing a two lumen band withintegrated lighting around the CMOS module;

FIG. 11 is a side view of an alternate embodiment of an outer catheterfor the coaxial bi-directional micro-endoscope with CMOS module, theouter catheter being a dual lumen catheter and the CMOS structureattached with polymer tubing;

FIG. 11A is an enlarged front view of the dual lumen outer catheter ofFIG. 11;

FIG. 12 illustrates a coaxial bi-directional micro-endoscope inaccordance with one embodiment of the present invention including thedual lumen outer catheter of FIG. 11 and the inner catheter of FIG. 5with a single deflecting lumen;

FIG. 13 illustrates a coaxial bi-directional micro-endoscope inaccordance with yet another embodiment including the dual lumen catheterof FIG. 11 and another embodiment of the inner catheter for dual lumendeflection as the coil covers both lumens;

FIG. 14 is a side view of another embodiment of a non-deflectablecoaxial micro-endoscope similar to the embodiment of FIG. 5 and havingdrainage holes;

FIG. 15 illustrates an enlarged top view of a distal portion of anotheralternate embodiment of a coaxial bi-directional micro-endoscopeconfigured with exit ports at its distal end;

FIG. 16 illustrates an alternate embodiment of a coaxial bi-directionalmicro-endoscope with CMOS module housing replaced with an adhesive;

FIG. 17 illustrates another embodiment of a coaxial bi-directionalmicro-endoscope with CMOS module attached to the distal tip of themicro-endoscope;

FIG. 18 illustrates one embodiment of a coaxial bi-directionalmicro-endoscope visualization system;

FIG. 19 illustrates another embodiment of a coaxial bi-directionalmicro-endoscope visualization system using a wireless router;

FIG. 20A is a side view of another embodiment of the coaxialbi-directional micro-endoscope of the present invention;

FIG. 20B is a front view of the micro-endoscope of FIG. 20A;

FIG. 20C is an enlarged view in partial cross section of the distalportion of the micro-endoscope of FIG. 20A.

FIG. 21A side view of another embodiment of the coaxial bi-directionalmicro-endoscope of the present invention;

FIG. 21B is a front view of the micro-endoscope of FIG. 21A;

FIG. 21C is a front view of an alternate embodiment of themicro-endoscope;

FIG. 21D is an enlarged view in partial cross section of the distalportion of the micro-endoscope of FIG. 21B;

FIG. 21E is an enlarged view in partial cross section of the distalportion of the micro-endoscope of FIG. 21C;

FIG. 22 is a side view of another embodiment of the coaxialbi-directional micro-endoscope of the present invention;

FIG. 23 is a front view of the micro-endoscope of FIG. 22;

FIG. 24A is a side view of an alternate embodiment of the mechanism fordeflecting the distal tip of the micro-endoscope with the lateralreinforcement tube removed for clarity;

FIG. 24B is a side view of the mechanism for deflecting the distal tipof the micro-endoscope of FIG. 24A with the reinforcement tube shown;

FIG. 25 side view of another embodiment of the coaxial bi-directionalmicro-endoscope of the present invention;

FIG. 26 is a side view of another embodiment of the coaxialbi-directional micro-endoscope of the present invention shown with avisualization system;

FIG. 27 is a side view of a distal portion of an alternate embodiment ofthe micro-endoscope of the present invention having a balloon; and

FIG. 28 is a side view of another embodiment of the coaxialbi-directional micro-endoscope of the present invention having apreformed distal portion.

DETAILED DESCRIPTION

FIG. 1 illustrates a first embodiment of a microcatheter 10. Themicrocatheter can be used with the non-deflectable or the deflectable(bi-directional) systems disclosed herein. The microcatheter is usedwith the imaging systems described herein to form the endoscope ormicro-endoscope (visualization device) of the present invention. Themicrocatheter can also be used with the inner catheters described hereinto form the deflecting micro-endoscope of the present invention. Each ofthese systems is discussed below.

The microcatheter 10 includes a catheter body 12 that runs from proximalend 14 to distal end 16. Catheter body 12 has a lubricious inner liner18 that runs from proximal end 14 to distal end 16. The purpose of theliner is to help reduce the coefficient of friction to aid in guidewiremovement within the lumen of the catheter body 12. The liner can be madeof materials such as polytetrafluoroethylene (PTFE) or fluorinatedethylene propylene (FEP). Other materials are also contemplated.

The liner is topped with an open pitch continuous coil 20 to help withlumen integrity (reinforcement) and to aid in stiffness variation. Thecoil 20, which can be made of flat or round wire or a combination, runsfrom proximal end 14 to distal end 22. The coil can be made of materialssuch as stainless steel, nitinol, polymer, platinum/iridium, fiber oreven a combination of materials. In addition, it can be open or closedpitch or a combination of the two. The coil can also be replaced in partor in whole by a braid.

The coil reinforcement layer is then topped with polymers with varyingstiffnesses to create three distinct sections: proximal section 24, midsection 26, and distal section 28. Proximal section 24 extends distallyfrom proximal end 14 to distal end 30. Mid section 26 extends distallyfrom distal end 30 of proximal section 24 to distal end 32. Distalsection 28 extends from distal end 32 of the mid section 26 to distalend 16. The stiffness will decrease from proximal section 24 to distalsection 28. Reduction in stiffness can be achieved by using decreasingdurometers of material from proximal to distal. Preferably, proximalsection 24 can be formed using materials such as nylon or pebax having adurometer in the range of 60 D to 75 D or any other material having arelative durometer hardness value of about 72 D, mid section 26 can beformed using a lower hardness material with a durometer of about 63 D,and distal section 28 can be formed with an even lower hardness materialsuch as a pellethane material having a durometer of 25 D to 55 D orother material having a durometer between about 25 D and about 40 D.These are just examples of materials and durometers that can be used asother materials and durometers are also contemplated. Also, each sectiondoes not need to be formed with a single layer of material, if desired,sections can be constructed of two or more layers. Actual materialselection will be based on design needs for flexibility and stiffness.Additional layers of coils or braids may also be added as needed. Ifneeded, marker band 34 may be placed near the distal end 16. The markerband can be made of platinum/iridium to aid in visualization underfluoroscopy or of other metals or plastics. The band can also be madefrom a coil rather than a solid tube as shown or even left off thedesign. These layers are then fused together using a re-flow process(heat). Coupled to the proximal end of outer catheter body 12 is wingedhub (luer) 36, which sits on optional strain relief 38. The winged hub(luer) 36 can be made of plastic.

As stated above, the typical microcatheter is formed using a re-flowtechnique which fuses all of the layers together with heat and, ifnecessary, removable heat shrink tubing. As the length, which can rangefrom about 0.5 inches to about 34 feet, increases to greater than about180 cm the use of the re-flow technique may be a problem due to currentequipment restrictions. An alternate method is to use non-removable heatshrink tubing of varying stiffnesses to create the proximal, mid, anddistal sections. Also, FIG. 1 shows one construction for a variablestiffness microcatheter. Other combinations or variations are consideredto be within the scope of this disclosure. If desired, the catheter neednot have any stiffness variation at all, it can be constructed of asingle durometer tube, an extrusion of single or multiple lumens,polyimide or metal (with or without laser cutting for flexibility). Thedesign concept described in FIG. 1 or something similar can be used forconstructing both the inner and outer catheters for the coaxialbi-directional micro-endoscope discussed below.

FIG. 2 illustrates a complementary metal-oxide-semiconductor (CMOS)imaging device or structure 40 such as those built by Fujikura (Japan)or Medigus (Israel). The structure 40 extends from proximal end 42 todistal end 44 and includes a CMOS module 46, lighting 48, miniaturecoaxial cables 50, and a connector 52. The CMOS module 46 is at thedistal end of imaging structure 40. The module 46 has a housing thatextends from proximal end 54 to distal end 44. The CMOS module houses(not shown) a lens, a CMOS sensor, and a flexible printed circuit (FPC),which are connected to the miniature coaxial transmission cables 50, allof which are glued together inside the housing. The CMOS module 46 has apreferred length of about 5 mm and a preferred diameter of about 1.2 mm.Other dimensions are also contemplated. The range of dimensions for thehousing will depend on the state of technology of the components insidethe housing. Today's CMOS sensors are large, as CMOS technology improvesdiameters for the overall part will decrease. The housing, which isround, is made of a rigid material. The housing can also be made of lessrigid materials such as polyimide or heat shrinkable polyethyleneterephthalate (PET), which would allow for a thin protective wall. Also,the housing need not be round, it can be oval or other shapes to reducethe overall OD to less than about 1.2 mm. Alternatively, the housing canbe left off and the lens, CMOS sensor, and FPC with miniature coaxialcables and optional strain relief can be encapsulated in a protectivelayer of adhesive that tapers down as it extends proximally as in theembodiment of FIG. 16 discussed below.

The CMOS module 46 is attached to miniature coaxial cables 50 thatextend from the proximal end 56 of the CMOS module to the distal end 54of the connector 52. The cables 50 connect the CMOS module as well aslighting 48 to connector 52. The length and number of cables will dependon the CMOS technology as well as the number of lights used in thesystem. The cables are shown straight, as an alternative they can bebraided, either in part or in whole, to form a tube with an inner walland an outer wall and distal and proximal ends.

The lighting 48 runs parallel to the CMOS module 46. The lighting can beflush with distal end 44 of the CMOS module or it can sit a distancedistal or proximal to the distal end 44 of the CMOS module. By adjustingthe placement of the lighting, more or less light will be provided tothe CMOS sensor. Alternately, the lighting can be integrated into theCMOS module 46 housing so that it is not separate. The lighting can beobtained from LED, glass or plastic fibers, or other forms of lightingthat are adaptable for lighting the area. The lighting may also be acombination of LED and fiber optic. This would allow an additionaladvantage of the distal tip being capable of being used for treatmentoptions such as laser lithotripsy or optical biopsy.

At the proximal end of the CMOS imaging structure 40 is the connector52. The connector is used to connect the imaging structure 40 to aninterface board/power for LED lighting (not shown). The interface board,which can have format connections such as USB, NTSC, and PAL, canconnect to a computer or video processor and monitor loaded withsoftware (not shown) for visual output. The interface board can also beconnected to a wireless router (not shown) that can be used towirelessly transmit the micro-endoscope images to computers, smartphones or even hand held tablets (such as IPads) that have theappropriate applications or software to receive and translate thesignals into images. As an alternative, the CMOS module 46 with lighting48 can be made wireless rendering the coaxial cables and the connectorunnecessary.

FIG. 3 illustrates one embodiment of a micro-endoscope of the presentinvention. The micro-endoscope includes the outer catheter of FIG. 1with imaging structure 58 at distal portion 70. The assembly includesthe CMOS module 46 and lighting 48 (of FIG. 2) that are attached withadhesive 60 to catheter body 12 so that the distal end 16 of catheterbody 12 of microcatheter 10 is flush with distal end 44 of the CMOSmodule 46 and lighting 48. Alternatively, the lighting 48 can bepositioned proximally or distally to distal end 44. The combinedassemblies are covered with a polymer heat shrink tube 62 that extendsfrom proximal end 64 to distal end 16. The shrink tubing 62 is thenheated so that the miniature coaxial cables and the exterior of theouter catheter are brought into close contact with one another forapproximately the useable length of the catheter. The shrink tubing 62forms an outer tube coaxial with catheter body 12. Any shrink tubing canbe used, but the preferred is a thin walled super flexible heat shrinktubing made of materials such as Pebax or Polyolefin as sold by CobaltPolymers (California, USA). The entire length from proximal end 64 todistal end 16 does not have to be covered by a single shrink tubing.Multiple shrink tubings with varying durometers may be used in asectional or overlapping method or non-shrinkable tube(s) that form aclose fit. As an alternate construction, the catheter body 12 ofmicrocatheter 10 can also be assembled leaving off the material layerthat makes up the three distinct sections as described in FIG. 1(proximal section 24, mid section 26, and distal section 28). In thiscase, the miniature coaxial cables 50 would lie on the reinforcementlayer and the shrink tubing 62 would cover the assembly. If needed,strapping to hold the outer catheter and miniature coaxial cablestogether in the form of short sections of heat shrink tubing such as PETcan be applied along the length of the assembly to help with handlingprior to shrinking outer cover. The outer cover would then be slid overthe entire assembly and shrunk down during manufacture. For either ofthe above constructions, the outer cover can alternatively be made of aclose fitting non-shrinkable plastic or other flexible shaft material.

The remaining free coaxial cables proximal to end 64 can also beencapsulated in a heat shrink tubing or extrusion 66 that may extend tothe connector 52. This shrink tubing can be of any durometer or it mayalready be present as part of the CMOS structure 40 as shipped from thefactory. An optional strain relief 68 can be placed over the proximalend of the catheter where the distal end 67 of the free miniaturecoaxial cables covered in shrink tubing or extrusion and the proximalend 64 of the outer catheter and coaxial cables covered in the polymercover meet.

The outer catheter with imaging structure 58 can form the outer catheterfor a non-deflecting stand-alone micro-endoscope or alternatively canform the outer catheter for the coaxial bi-directional (deflectable)micro-endoscope. In either version, the CMOS structure is mountedexternal of the outer catheter to thereby minimize the outer diameter ofthe outer catheter to facilitate insertion and due to the reducedprofile, access body structure which might otherwise not be accessiblewith larger diameter catheters. In the non-deflecting stand-aloneversions, in one embodiment by way of example, the inner diameter of themicro-endoscope (i.e., the inner diameter of the outer catheter) willhave a working channel sufficient to accept up to about a 4 French(0.052″) working device, such as retrieval basket device, laser device,or biopsy forceps. In another embodiment, the working channel will havea diameter small enough to provide an acceptable lumen for tracking a0.005″ guidewire. Also, if used as a stand-alone device, a hydrophiliccoating may be added to the outer diameter as well as an RHV on theproximal end to allow flushing and irrigation and/or insufflation of thedistal tip. The flushing/irrigation can clean the imaging structure.Note the outer catheter can be tracked over a guidewire.

The visualization system described so far has been using CMOS sensortechnology. It is understood that other visualization and/or processingtechnologies exist including fiber optic, charged-couple device (CCD)sensors, narrow band imaging (NBI), and optical coherence tomography, toname a few. Utilizing one of these options or a combination of a few isconsidered to be within the scope of this disclosure. These options canbe utilized with the non-deflectable as well as with the deflectablemicro-endoscope embodiments disclosed herein.

An alternate embodiment of the micro-endoscope is shown in FIG. 4. Themicro-endoscope has imaging structure 72 at distal portion 74.Construction is much the same as FIG. 3 except that the CMOS module 46and the lighting 48 are free of the shrink tube 62 so that distal end 44of the CMOS module 46 and lighting 48 are distal of the distal catheterend 16. The CMOS module is shown unattached in FIG. 4, however, itshould be appreciated that in assembly the CMOS module will be attachedto an inner catheter extending through a lumen in catheter body 12 suchas in FIGS. 7-9 discussed below.

FIG. 5 illustrates one embodiment of a coaxial bi-directionalmicro-endoscope 76 with distal deflectable portion 86. In theembodiments herein where the micro-endoscope tip can be deflected, thisis achieved through the interaction of the inner and outer catheters andthe column member attached to the inner catheter which is surrounded bya lateral reinforcement tube. This is described in detail below.

Turning to the embodiment of FIGS. 5-6D, coaxial bi-directionalmicro-endoscope 76 includes the outer catheter of FIG. 3 (designated byreference numeral 117) fitted with a rotating hemostatic valve (RHV) 78,an inner catheter assembly 80 slidably disposed in the outer catheterinner lumen, a distal coil 98, and marker band 100. It also includesimaging structure which is similar to imaging structure 58 of FIG. 3.The coil 98 is preferably a helically wound flexible coil. The coil maybe made from a polymer, metal or combination thereof, but the preferredcoil material is platinum/iridium for radiopacity. In addition, it canbe made of a solid tube, either plastic or metal with or without lasercutting to introduce flexibility. Marker band 100 can be a solid tube ora flexible helical wound coil. Either option can be made from a polymeror metal, the preferred material is platinum/iridium for radiopacity.

The inner catheter body 82 of inner catheter 80 runs from proximal end94 to distal end 96 and is configured with an outer diameter capable ofbeing slidably positioned inside the outer catheter. The overall useablelength of inner catheter 82 can range from as short as 0.25 feet togreater than 18 feet with a preferable length between approximately 15cm (0.5 feet) to 400 cm (13 feet). Catheter body 82 extends a distancepast distal end 16 of outer catheter 12 to distal end 96. The distalexposed end of the inner catheter 80 is configured for deflection andcovered with a coil 98 that extends from outer catheter distal end 16 todistal end 102. The distal deflectable portion 86 can include a markerband 100 at the very distal end attached to coil 98 and/or underlyinginner catheter portion. The length of the distal deflectable portionwill be based on the length of the exposed inner catheter. In oneembodiment, the distal exposed end of the inner catheter can range fromapproximately 5 to approximately 9 mm resulting in a bend radius ofapproximately 3.5 mm. The preferred bend radius will depend on the needfor which the coaxial bi-directional micro-endoscope is designed.

The proximal end of inner catheter assembly 80 includes a winged hub(luer) 90 and optional strain relief 92 coupled to catheter body 82.Attached to winged hub 90 is RHV 88 with side arm 84 and end cap 83. Endcap 83 allows access to the working channel of the inner catheter 80 ofthe coaxial bi-directional micro-endoscope for passage of guidewires,forceps, or other accessories needed for carrying out diagnostic ortherapeutic functions. In one embodiment, the inner diameter of theinner catheter assembly 80 will have a diameter sufficient to accept upto a 4 French (0.052″) working device, such as retrieval basket, cuttingwires, or biopsy forceps. In another embodiment, the working channelwill have a diameter small enough to provide acceptable tracking for a0.005″ guidewire. Side arm 84 allows flushing and irrigation and/orinsufflation.

The largest outer diameter for the coaxial bi-directionalmicro-endoscope 76 will be in the distal portion where the CMOS module110, catheter body 82, and polymer shrink tubing 119 come together. Asnoted above, the imaging structure can be the same as imaging structureof FIG. 3. In some embodiments, the distal portion of themicro-endoscope 76 has an outer diameter that can range betweenapproximately 3 French and approximately 14 French, and preferablybetween approximately 4.5 French and approximately 10 French.

The proximal winged hub 104 on the outer catheter 117 is fitted with RHV78 with end cap 106 and side arm 108. The purpose of end cap 106 is toprovide a lock for holding the inner catheter 80 in position. That is,end cap 106 can be rotated in a first direction to clamp and secure theinner catheter 80. The purpose of side arm 108 is to provide access tothe inner lumen formed between the coaxial inner and outer catheters solubrication, irrigation, and/or insufflation can be introduced. In thedeflectable micro-endoscope embodiments which utilize relative movementof the inner and outer catheters to deflect the distal tip, lubricationcan be provided during the procedure to provide smoother movement ofthese components and thereby facilitate deflection. Fluid introducedthrough side arm 108 can exit holes 111 in the outer shaft or gaps 99 indistal tip coil 98. The RHV 78 is one example of a locking/lubricationsystem for the coaxial bi-directional micro-endoscope. Other designs maybe used to accomplish the same goals.

As noted above, the outer catheter is one part of the overall assemblyof the coaxial bi-directional micro-endoscope 76. Likewise, the outercatheter can be added as an outer shaft to existing medical devices suchas endoscopes, deflectable (micro) catheters employing push/pull wires,balloon catheters. In that case, the catheter 10 can optionally beeliminated and imaging structure 40 can be placed directly on the outerdiameter of the alternate device using the polymer shrink tubing 62 oranother close fit polymer tube.

FIG. 6A shows an enlarged top view of distal deflectable portion 86 ofthe coaxial bi-directional micro-endoscope 76 of FIG. 5 being deflected.When the end cap 106 on RHV 78 is in the open position, the innercatheter 82 is free to move relative to the outer catheter. The back andforth axial motion causes the distal tip 112 to deflect as described inmore detail below. The distal tip 112 may be locked in position at anypoint by tightening the end cap 106 which locks the inner catheter 82 inposition. Also, the tip is shown deflecting perpendicular to the CMOSmodule 110. This is shown as an option. The CMOS module 110 can beplaced at any position or orientation relative to the deflectable tip.

The deflection structure 113 used to deflect distal portion 86 is shownin FIGS. 6B-6H. The deflection structure is comprised of the outercatheter 117, inner catheter 82, column 121 and lateral (axial)reinforcement (support) tube 125. Also, a deflectable marker band 115,spiral cut tube 119, and marker band 123 are provided.

In assembly, marker band 115 is inserted mid-way into the distal end ofouter catheter body 117 and bonded to form a lip. Inner catheter 82 hasa distal spiral cut tube 119 at its distal end and is inserted throughouter catheter 117 and marker band 115 until it extends a distance pastthe distal end of outer catheter 117 and marker band 115. The proximalend of column 121 is attached either to the surface of marker band 115or inserted into the distal end of outer catheter 117 between the markerband 115 and the inner lumen of the outer catheter 117 and thenattached. The distal end of column 121 is attached to the distal end ofspiral cut tube 119 of inner catheter 82 using marker band 123.

The underlying column theory used to deflect distal section 86 will nowbe described with reference to FIGS. 6C and 6D. Without a lateral(axial) reinforcement (support) tube 125, which in the embodiment ofFIG. 6D is a coil, when a proximal pull force is applied to innercatheter 82 to move inner catheter 82 proximally (or alternatively whenouter catheter 117 is moved distally, or both catheters are moved inthese directions relative to each other), spiral cut tube 119 will bepulled proximally resulting in attached column 121 compressing (FIG.6C). However, when lateral reinforcement tube, e.g., coil 125, is addedto deflection structure 113 to surround column 121, and the sameproximal axial force is again applied, the distal tip, which can nolonger compress, will deflect due to the reinforcement tube (coil) asshown in FIGS. 6D and 6E. Note column 121 contacts an inner wall of tube125 during deflection. If the inner catheter 82 is moved axiallydistally (or alternatively when outer catheter 117 is moved axiallyproximally or both catheters are moved in these directions relative toeach other) the column 121 will bend and the distal tip will deflect inthe direction of the tip as shown in FIG. 6F. Note column 121 will againwant to contact the inner wall of tube 125, however, in this case,lateral reinforcement tube 125 will serve more to keep componentstogether in the bend. Such tip deflection is shown in FIGS. 6G and 6H.Note that by varying the dimensions, i.e., cross-sectional dimension, ormaterials or cuts, of the column 121 the load to deflect the distal tipcan be increased or decreased. For example, increasing the dimensionswill increase the force required to deflect the distal tip. Note thoughif the column dimensions become too thin, the column will becomeunstable leading to multiple buckling points under load. This willresult in little or no tip deflection. Further details of the columntheory are discussed below.

Note, in these Figures, the tip of the inner catheter deflects while thetip of the outer catheter does not deflect or substantially deflect.

The marker bands 115 and 123 can be made of any metal or a polymer tubeor coil with a preferred material of platinum/iridium. The deflectionstructure 113 can even be designed leaving these parts out or incombination with the column 121. The preferred cross section of column121 is non-circular, and preferably rectangular, so deflection occurs inthe desired plane, however other shapes such as round can be used. Also,cuts or other features can be added to the column to influence movement.The column 121 can be made of any metal or metal alloy and even aplastic, however the preferred material is a super elastic nitinol orspring tempered stainless steel wire or rod. Spiral cut tube 119 neednot have a spiral cut pattern. It can have any laser cut pattern thatwill influence flexibility. It can also be made of any metal, polyimideor plastic but the preferred material is super elastic nitinol or springtempered stainless steel. The tube may also be coated in a thin polymerand contain a lubricious inner liner. Alternatively, the tube can alsobe made of a coil or a braid that may include some plastic or a solidplastic tube. The cuts will affect the load to deflect the tip.

FIG. 7 illustrates another embodiment of a coaxial bi-directionalmicro-endoscope 114 assembled with an outer catheter (e.g., the outercatheter of FIG. 3), an imaging structure 72 and inner catheter 80.Inner catheter 80, which in this embodiment is the same as innercatheter 80 of FIG. 5, is shown placed inside the outer catheter. Inthis embodiment, the CMOS module 46, lighting 48, and a portion ofminiature coaxial cables 120 extend distal of distal end 116 of theouter catheter so that they can be mounted at the distal end 118 ofdeflecting tip 122.

In one mounting method, shown in FIG. 8, CMOS module 46 and lighting 48of coaxial bi-directional micro-endoscope 114 are mounted parallel todeflecting tip 118 at distal portion 124. They are held in place withadhesive or solder 126 near optional marker band 128. The cables aredesignated by reference numeral 120. The distal end 132 of CMOS module46 extends past the distal end 130 of the catheter 80. The offsetbetween the distal end 130 of the catheter and the distal end 132 of theCMOS module is so that the hard housing of the CMOS module 46 will notaffect deflection. The lighting 48 is also shown offset to the distalend 132 of the CMOS module 46, not flush. This is just an example ofplacement. Lighting can be placed at any location that will most benefitthe CMOS module 46.

An alternate mounting method is shown in FIG. 9 wherein a perpendicularmounting of the CMOS module 46 and lighting 48 relative to deflectingtip 118′ on distal portion 124′ distal of inner catheter 80′ isillustrated. In this embodiment, CMOS module 46 and lighting 48 aremounted flush to the distal end 130′ and perpendicular to the deflectingtip 118′. This mounting causes the CMOS module 46, lighting 48 and theminiature coaxial cables 120 to kick out so as not to affect deflection.

A cover 136 can be utilized (not deflecting) with a perpendicularmounting as shown in FIGS. 10 and 10A. The cover 136 extends fromproximal end 138 to distal end 140 and covers entire deflecting tip 118.The cover may extend over the outer catheter with polymer cover, ifdesired. The cover 136 is preferably made from a highly flexiblematerial such as polyisoprene but can be made of other polymers such asHDPE, LDPE, CFlex, latex, silicone, nitrile, pebax, nylon, orpolyurethane. If a solid non-flexible type polymer tube is used, lasercut holes or cuts can be introduced to allow fluid introduced throughthe RHV to flow out. As an alternative, a balloon like polymer can beused as cover 136. In this case, fluid introduced through the RHV wouldcause inflation. The cover 136 can also be made from a coil or laser cutmetal (for flexibility) using metals such stainless steel, nitinol,platinum/iridum, or even fibers.

In this embodiment, all of the components are integrated into markerband 142, which has two lumens, lumen 144 and 146. The marker band 142may be made from metals such as stainless steel, platinum/iridium oreven plastics such as HDPE, LDPE, or Pebax. These are just examples ofdifferent options for providing a two lumen structure.

Lumen 144 contains CMOS lens 148 and several lighting fibers 150arranged in a ring around lens 148. Lens 148 and lighting fibers 150 arejoined to marker band 142 with adhesive 152. The lighting 150 can befrom a variety of sources such as LEDs and/or fibers made of glass,quartz or polymers. As an alternate, the ring of lights can be used forboth lighting and as a laser source for treatment options such aslithotripsy or optical biopsy. This is done through configuring thelaser source to switch back and forth between lighting and firing or byincluding dedicated lithotripsy or biopsy fibers in the ring next to thelighting fibers.

Lumen 146 of marker band 142 contains the inner lumen 154 of the innercatheter 154. This is the working channel (lumen) of the coaxialbi-directional micro-endoscope through which guidewires and accessoriesare introduced for gastroenterology (GI) or ear, nose throat (ENT)procedures, for example. Above the inner lumen 154 is the column 156,which as described above is used in deflection of the distal tip. Thecolumn 156 and inner lumen 154 are bonded together with adhesive 158.Surrounding the marker band 142 is cover 136, which is bonded to markerband 142 with adhesive 160. If desired, cover 136 can stop proximal ofthe marker band 140 so as not to cover it.

FIGS. 11 and 11A illustrate a top view of an alternate embodiment of acoaxial micro-endoscope 161 having a dual (two) lumen outer catheter andan imaging capability assembly. The micro-endoscope includes outercatheters 164 and 166, CMOS module 168, and miniature coaxial cables169, all encapsulated by polymer cover 171. Extending from the proximalend of polymer cover 171 is polymer cover 173, which is coupled toconnector 177. An optional strain relief (not shown) covering distal endof cover 173 and proximal end of cover 171 could be provided. Coupled tothe proximal end of catheters 164 and 166 is tri-furcate hub 170 withoptional strain relief 172. This embodiment allows the micro-endoscopeto have two working channels (lumens). One channel can be used forirrigation and/or insufflation while the other can be used for GI or ENTtreatment options, for example. Other lumens may be added for additionalirrigation or a shorter lumen can be added to make the coaxialbi-directional micro-endoscope into a rapid exchange device.Alternately, a polymer multi-lumen extrusion or metal tubing can be usedas a substitute for the combining separate catheters. This may bevariable stiffness or just a single durometer. Outer catheters 164 and166 can be formed as separate tubes attached together or formed as asingle tube with two lumens.

Tri-furcate hub 170 has two side arms, 174 and 176, and end cap 178.Side arm 174 is for access to the inner lumen of catheter 164 and can beused for introduction of accessories or irrigation/insufflation. Sidearm 176 is for access to the inner lumen of catheter 166 and can also beused for introduction of accessories or irrigation/insufflation. End cap178 is for used for locking an accessory within the inner lumen 166 aswell as access to the inner lumen through which the inner catheterassembly can run. Tri-furcate hub 170 can be replaced with a molded partdesigned to do the same functions. It can be molded out of plastic ormachined of metal.

The CMOS module 168 is placed on top of catheter 164 and catheter 166with lighting 180 and 182 on either side of the CMOS module 168. All ofthe components can be bonded by adhesive 184 and surrounded by polymercover 171. If desired, one lighting unit (for instance 180) can be usedfor laser treatments such as lithotripsy or visualization using narrowband imaging while the other (182) is strictly for lighting. Thelighting can come from LED, fibers, or other adaptable sources. Also,although most embodiments have mentioned using CMOS as imaging system,module 168 can be any imaging technology, such as CCD, fiber optics,narrow band, or optical coherence tomography to name a few.

FIG. 12 illustrates an alternate embodiment of the dual lumen coaxialbi-directional micro-endoscope with imaging capability. Themicro-endoscope 186 includes an outer catheter assembly 162 includingtwo outer catheters (tubes) 164 and 166 positioned side by side as inFIG. 11, inner catheter assembly 185 extending through one of the outercatheters, coil 188 which forms the lateral reinforcement member for thecolumn, and marker band 190 at distal end 192. The coil 188, which formsthe lateral reinforcement member for the column, covers the exposeddistal end of inner catheter 185 and deflection components (not shown),e.g., the column member, attached to outer catheter 166 and extendingdistally therefrom. Coil 188 extends distal of distal end 194 of outercatheter 166 of outer catheter assembly 162 to distal end 192. The coil188 can sit directly on outer catheter 166 or near the end of it. Thepreferred material for the coil is platinum/iridium but any metal,plastic or combination of both can be used. Laser cutting may be used onsolid tubing to cut slots to increase flexibility and bending. Coil 188does not cover distal end 196 of catheter 164.

In an alternate embodiment of the dual lumen coaxial bi-directionalmicro-endoscope with dual lumen deflecting tip, both catheters/lumensare deflectable. In this embodiment (FIG. 13), micro-endoscope 198 has acoil 187, forming the lateral reinforcement tube for the column member,which extends from the distal end 196 of outer catheter 164 and distalend 194 of outer catheter 166 to distal end 192. This creates a duallumen deflectable tip. Deflection in the embodiments of FIGS. 12 and 13,as well as in the other embodiments disclosed herein, are achieved inthe same manner as discussed above, i.e., the column 121/coil 125 ofFIGS. 6D and 6G.

FIG. 14 illustrates another embodiment of a non-deflectable coaxialmicro-endoscope 200. It includes inner catheter assembly 202 with RHV218, and an outer catheter 212 with imaging structure 201 and RHV 204.The outer catheter 212 can be the same as the outer catheter of FIG. 5.The inner catheter assembly 202 and outer catheter are lined up so theyare flush at distal end 208.

Attached to the proximal end of inner catheter assembly 202 is REV 218with side arm 222 and end cap 220. End cap 220 allows access to theworking channel of the inner catheter 202 of the micro-endoscope 200 forpassage of guidewires, forceps, or other accessories needed for carryingout diagnostic or therapeutic functions. Side arm 222 allows flushingand irrigation and/or insufflation through the distal tip. As mentionedabove, this flushing, as in the other embodiments disclosed herein, aidsvisualization.

Attached to the proximal end of outer catheter 212 is RHV 204. Side arm214 on RHV 204 is used for lubrication of the inner lumen as well as forirrigation/insufflation of the distal tip through laser cut holes 210 inthe outer catheter 212. Such irrigation can aid visualization. Inaddition, fluid/air will also exit distal tip 216. If a larger workingchannel is needed, the inner catheter assembly 202 can be removedproximally by unlocking end cap 206 and withdrawing inner catheter 202from outer catheter 212. This will make the micro-endoscope a singlelumen device with a larger internal diameter for introduction of devicestherethrough. Such removability is also applicable to the otherembodiments disclosed herein where the imaging structure is attached tothe outer catheter.

FIG. 15 illustrates distal portion 224 of another embodiment of adeflecting coaxial bi-directional micro-endoscope. It includes innercatheter 226, outer catheter 228 with laser cut holes 230, CMOS module232 with miniature coaxial cables 244, polymer cover 246, distaldeflecting tip 234 with coil 236 having gaps 238, and distal end 240.When fluid 242 is introduced through an RHV (not shown but preferablythe same as the RHV of FIG. 14) connected to the proximal end of outercatheter 228, it will exit holes 230, gaps 238, and distal end 240. Thiswill provide irrigation for clearing material in front of the CMOSmodule and help prevent clouding during image acquisition. The flushingcan occur at any point during deflection or it can be continuous. Theholes and gaps also allow optional insufflation.

Another embodiment of the coaxial bi-directional micro-endoscope isdesignated by reference numeral 248 and illustrated in FIG. 16. Thedistal portion 250 includes outer catheter 252, flexible printed circuit(FPC) 254, adhesive 256, lens 258, lighting 260, CMOS sensor 262,optional strain relief 268, coaxial miniature cables 264, an adhesivebarrier 266, and polymer cover 270. FPC 254 has lens 258, CMOS sensor262, coaxial miniature cables 264, and option strain relief 268 attachedthereto. The FPC 254 is attached to outer catheter 252 and lighting 260with adhesive 256. The FPC 254 with attached components is encased inadhesive barrier 266, which has taper 270 that tapers from distal toproximal. The approximate usable length of the outer catheter, includingdistal tip with FPC and components, is covered with a polymer cover 272.The purpose of the adhesive barrier 266 is to provide an alternative tothe round housing such as in FIG. 14 to protect the FPC 254 and itsattached components. It addition, it tapers down proximally removing thesquare edge of the housing. If a rigid housing is used instead ofadhesive barrier 266, a tapered part can be inserted proximal to theproximal edge of the housing to remove the step. A protective shrinktubing such as PET or thin walled polyimide can also be used as asubstitute for the housing. In addition, the FPC 254 can be curved withrounded edges. This will allow it to sit on the catheter outer diametermore firmly and remove sharp edges that may cut heat shrink tubing. Notethe aforedescribed structure can be utilized with the outer catheterused in the non-deflecting as well as in the deflecting tip embodiments.

An alternate embodiment of a coaxial bi-directional micro-endoscope 274with CMOS module and integrated lighting 276 mounted at the distal end278 is shown in FIG. 17. Such mounting can be utilized withnon-deflecting and deflecting versions of the microendoscope.Micro-endoscope 274 includes an outer catheter 280 fitted with rotatinghemostatic valve (RHV) 282, an inner catheter assembly 284 disposed inthe outer catheter inner lumen, a distal coil 286, and CMOS module andintegrated lighting 276. The inner catheter assembly 284 includescatheter body 288, RHV 290, winged hub (luer) 292, and optional strainrelief 294. The catheter body 288 runs from proximal end 296 to distalend 278 and is configured with an outer diameter capable of beingpositioned inside the outer catheter 280. Inner catheter body 288extends a distance past outer catheter distal end 298 to distal end 278.The distal exposed end of the inner catheter 288 is configured fordeflection (not shown) in the same manner as in FIGS. 6D and 6G and iscovered with a coil 286 that extends from outer catheter distal end 298to distal end 278 and forms a lateral reinforcement (support) tube forthe column. A removable wire 300 can be utilized, extending through theinner lumen of inner catheter body 288 for support to aid in introducingand pushing the micro-endoscope 274. The wire 300 can be locked in placewith rotational end cap 302 which when rotated in one direction clampswire 300.

The proximal end of the miniature coaxial cables and lighting arecovered in plastic 304 (either extrusion or shrink tubing) and extendout of side arm 306 on RHV 290 and connect to connector 308. If desired,the cables and cover can be glued in place in arm 306. The distalsection of the miniature coaxial cables run through the inner lumen ofthe inner catheter body 288 and exit distal end 278 where they areattached to the CMOS module and lighting 276, which is glued or solderedin place to coil 286. The attachment could be similar to that of FIG.20A or 21A.

The proximal winged hub 310 on outer catheter 280 is fitted with RHV 282with end cap 312 and side arm 314. The purpose of end cap 312 is toprovide a lock for holding the inner catheter assembly 284 in position.When end cap 312 is opened, the inner catheter assembly 284 is free tomove axially back and forth resulting in deflection of the CMOS module276 in the manner described above and shown for example in FIGS. 6D and6G. The purpose of side arm 314 is to provide access to the inner lumenformed between the coaxial inner and outer catheters solubrication/irrigation and/or insufflation can be introduced. Distalexit ports 316 can be laser cut into the shaft or gaps 318 can be madein coil 286 for the fluid and/or air to exit. The RHV 282 is one exampleof a locking/lubrication system for the micro-endoscope. Other designsmay be used to accomplish the same goal.

FIG. 18 illustrates an embodiment of a coaxial bi-directionalmicro-endoscope visualization system 320. Visualization system 320includes coaxial bi-directional micro-endoscope 322 with connector 52,interface board/LED power source 324, USB connector and cable 326, andcomputer 328 loaded with visualization software. The micro-endoscopeillustrated is the embodiment of FIG. 5, but the other micro-endoscopesdisclosed herein can also be used with the visualization system 320. Inuse, a coaxial bi-directional micro-endoscope 322 with connector 52 isremoved from packaging. Connector 52 is connected to interface board/LEDpower source 324, which is in turn connected to a computer 328 or videoprocessing/monitoring/recording system loaded with necessary softwareusing USB connector and cable 326. Once the visualization system isready, a guidewire is inserted through the working channel of coaxialbi-directional micro-endoscope 322 and the combined assembly is insertedinto the working channel of a larger endoscope for tracking to the areaof interest inside the body. Once there, images can be viewed andrecorded. If needed, the working channel of the micro-endoscope can beused for diagnostic and/or therapeutic procedures once the guidewire isremoved. When the end cap on the outer catheter's RHV is open, movementof the inner catheter body (or outer catheter relative to the innercatheter) will result in deflection as described above. Irrigationand/or insufflation can be introduced through the side arm on the outercatheter RHV. After the procedure is completed and the device isremoved, connector 52 is disconnected from interface board/LED powersource 324 and the coaxial bi-directional micro-endoscope 322 can eitherbe discarded or cleaned using appropriate methods depending on whetherit is designed as a disposable or re-usable or re-sterilizable device.Although interface board/LED power source 324 is shown connected to acomputer 328 using USB connector and cable 336, other connectors andformats can be used, for instance NTSC or PAL to connect to otherviewing options so long as they have the appropriate software. Also, thepower source for the LED lights can be a separate component that isself-powered (battery) or plugged into a wall socket. The stepsdescribed above for preparation and use of the coaxial bi-directionmicro-endoscope are only an example of how the scope can be prepared andused. They are not meant to be the standard. For instance, the guidewiremay be optionally left out if tracking is not required of the device orthe coaxial bi-directional micro-endoscope can be used as a standalonedevice not requiring another endoscope.

FIG. 19 illustrates an alternate embodiment of a coaxial bi-directionalmicro-endoscope visualization system 330. Visualization system 330includes coaxial bi-directional micro-endoscope 322 with connector 52,and wireless router/LED power source 332. The micro-endoscopeillustrated is the embodiment of FIG. 5, but the other micro-endoscopesdisclosed herein can also be used with the visualization system 330. Inuse, the coaxial bi-directional micro-endoscope 322 is connected towireless router 332 by connector 52. The wireless router would transmitsignals received from the coaxial bi-directional micro-endoscope 322 toany system that has the appropriate software for receiving and viewingand/or recording. Examples include, but are not limited, to a computer328, tablet (IPad) 336, or smart phone 334. As an option, additionalsoftware and applications can be developed for the coaxialbi-directional micro-endoscope. An example is an application combiningthe visual data from the CMOS module with the radiographic data fromfluoroscopy.

FIGS. 20A-20C illustrate a coaxial bi-directional micro-endoscope 337with distal portion 338, similar in construction to coaxialbi-directional micro-endoscope 274 shown in FIG. 17 except in thisembodiment, the lighting used for illumination for CMOS camera 340mounted at distal end 342 is optical illumination fibers 344. As statedearlier, the fibers may be made of glass, plastic or other material usedfor making optical illumination fibers. For this embodiment, thepreferred fiber is made of polymer or plastic with an outer diameter ofaround 0.010″ to 0.020″. More or less than two fibers can be used aswell as different diameter or shaped fibers or mixed fiber materials.Additionally, the camera may have a lens, which may be round, square orother shape, made of glass, polymer, quartz, or combined materials. Thelens can be added to the camera before the tip is assembled in-houseusing typical endoscope or camera manufacturing methods or it can beshipped from the manufacturer in place.

The fibers 344 are mounted below the camera 340 and above the innerlumen 346, as shown in FIG. 20B. A cover 348 is placed over camera 340,fibers 344, and inner lumen 346 (shown with guidewire 347 positionedtherein) and encased in epoxy or adhesive 350. The cover 348, which forexample, may be made of metal, plastic, or shrink tubing runs fromdistal end 342 to proximal end 352. In addition, if the cover is a bandor a laser cut tube, it may have holes for adding glue to inner contentsand a slot for sliding the camera body into. Also, although the cover348 is shown round, it can be other shapes such as oval or square tominimize dimensions. The edge between the proximal edge 352 of the cover348 and outer coil 354 may be taken off by the application of adhesiveor solder 356 around the edges. Alternatively, the epoxy or adhesiveunder the cover can be left out or used to tack parts and the entiredistal assembly can be encased in plastic melted down to form an coverusing removable heat shrink tubing. This cover may be more oval thanround due to parts being squeezed together. Once assembled, and, ifnecessary, the distal tip can be polished. In some instances, polishingmay not be required. The fibers run through the catheter from distal end342 to proximal end 358 where they are glued into connector 360 andpolished. The manufacturing description provided for polishing distaland proximal ends is merely exemplary and not limiting on how the finaldevice is assembled in manufacturing.

FIG. 20C shows a side view of the distal portion 338 with the outer coil354 in cross section and cover 348 removed to better understand cameramounting. As shown in FIG. 20C, the camera 340 is connected to a flatribbon power and data cable 362 that runs through the catheter from thecamera's proximal end 364 to the end 366 (FIG. 20A) where it is attachedto a USB type connector 368. The cable 362 is outside the innercatheter. The flat ribbon power and data cable 362, as used by Awaiba(Germany) to connect the NanEye CMOS camera head to the USB base station(not shown) may have cross sectional dimensions around 0.72 mm wide(0.0283″) and 0.188 mm (0.0074″) thick. To make the ribbon moreconformable to the inner lumen of the outer catheter or any cover tube,the ribbon may be cut in two to create two separate groups of wires.Alternatively, the wires can be separate from one another as shown inearlier drawings. Also, in order to reduce device distal outer diameterfurther, a thin walled tube can be inserted into the distal end of innerdiameter of inner catheter and glued in place. The camera and lightingcan then be glued on that structure with cover tube.

As shown in FIG. 20C, the flat ribbon 362 is configured so that the thindimension is parallel to the thin dimension of the column 370 which hasa free length L of about 6 mm, although other dimensions arecontemplated. This configuration allows for optimal bending. The column370 shown in this particular configuration is made of spring-temperedstainless steel, however other materials such as Nitinol can be used.The column is 0.002″ thick and 0.006″ wide but, depending on what isbeing deflected, can be made thicker or wider and even round. The column370 is covered by a reinforced (support) tube in the form of outer coil354 and together function to effect deflection according to the columntheory described herein. Column member 370 is attached to marker bands372 and 374. Marker band 374 is positioned so it extends partially fromouter catheter 337 to form a lip on which the coil 354 proximal end isglued in place (glue not shown). Inner catheter 339 runs through markerbands 372 and 374 where its distal end is aligned with the fibers andcamera. Both the ribbon and the fibers run under distal marker band 372and through proximal marker band 374 where they enter the inner diameterof the outer catheter 337. The inner catheter distal end, fibers and thecamera can be tacked in place at distal end (not shown) to holdalignment before a cover (not shown) is added. Alternatively, a covercan be added and glue can be wicked in.

Inside the outer catheter 335, the data cable and fibers can be held incontact with the outer diameter of the inner catheter 339 using flexibleplastic tubing, polyimide tubing, bands at set distances, glue, or otherby other tacking methods. The fibers and data cables can also be leftfree to float inside the outer catheter inner diameter. Note, if anouter tubing (such as polyimide) is used to keep the fibers/flat ribbonpower and data cable and inner catheter together, it may be set asufficient distance proximal of the deflection section of the catheterso as not to interfere with the push deflection. The distance may beabout 1 cm or greater from distal end 342. Glue joints should be appliedto the distal and proximal ends of the outer tubing so as to join thetube with the inner contents, allowing them to move as a unit with theinner catheter. If the outer tubing has to run through the deflectionarea, it should be laser cut to allow bending.

The fiber and the flat ribbon cable exit the proximal end of thecatheter assembly through arm 376 of RHV 378 where they are covered withthe flexible tube 380. RHV 378 is purely exemplary, the handle can bemolded or designed to fit the design need. In addition, although allmovement has been shown to be purely axial, the proximal handle can befitted with a screw system making proximal movement rotational to bringabout axial deflection. Tube 380 may be made of a spiral cut PTFE orother highly flexible tubing. A connector 382 at the proximal end oftube 380 connects to a bifurcation member 384 to separate the fibersfrom the cable. The fibers and cable each have a cover tube 386 and, ifnecessary, strain relief covers (not shown). Additionally, stainlesssteel mandrels (not shown) may be added to the inside of the cover tubesto help with any bending due to the weight of the connectors. The abovedimensions, materials, and construction shown are exemplary and are notlimiting in any way. In addition, the catheter may be assembled insub-assemblies and assembled into a full catheter using interventionalcatheter manufacturing techniques combined with laser fiber catheter orendoscope techniques.

In an alternate embodiment, the spiral tube is not provided and the datacable 362 can be used to deflect the distal tip. That is, the cable canbe attached to a distal end of the column moved axially proximally ordistally relative to the outer catheter 335, and thereby function toeffect deflection in the same manner as the axially movable innercatheters described herein effect deflection due to the interaction ofthe column 370 and outer reinforcement coil 354 (or tube). This can alsobe achieved by use of a laser fiber or other imaging component attachedto the column member movable to deflect the tip. This is discussedbelow.

FIGS. 21A, 21B, and 21D illustrate another embodiment of a coaxialbi-directional micro-endoscope 388 without a guidewire lumen to reducethe overall outer diameter of the distal tip as well as the overalldevice diameter. In this embodiment, the illumination fibers 390 andpower and data cable 392 (located inside tubes 394 and 396,respectively) run through the center of the outer catheter body 398,which is made up of a variable stiffness shaft 400 and distal coil 402,and are covered distally by cover 404. The variable stiffness shaft 400is reinforced and has a lubricious inner liner, similar to amicrocatheter. The inner diameter of the outer catheter body is about0.042″ with an outer diameter of about 0.050″. The distal coil 402 canbe made of any material and may even be laser cut and/or covered inplastic to make air/liquid tight and contain an inner lubricious liner.If laser cut, cutting must be done so that bending is optimized. Also,the laser cut version of the cover can be part of a complete outercatheter body and not two separate parts, as shown. As shown in FIG.21B, cover 404 covers CMOS camera assembly 406, illumination fibers 390,and a flush hole 408. The cover 404 can be made of a metal, polymide,plastic or other material or a coil with all components potted in epoxyor glue 410. Plastic tubing can also be shrunk down to create a coverusing removable heat shrink tubing. In this case, the resulting tip maybe oval more than round due to squeezing of the parts together. Glue orsolder 412 can be used to create smooth transition between proximal endof cover 404 and distal end of distal coil 402.

The illumination fibers 390 and power and data cable 392 run inside apolyimide tube 413 with an inner diameter of about 0.034″ and an outerdiameter of about 0.040″. The polyimide tube dimensions can vary so longas the illumination fibers and power and data cable can be snakedthrough the tube's inner diameter and tube movement is free relative tothe inner diameter of the outer catheter body. Or, if desired, the partscan be held together by bands, glue, shrink tubing, other methods oreven left free inside the outer catheter body. An optional stainlesssteel or other material wire can be added to the fibers and camera cableassembly to help with axial movement and tracking. The polyimide tube413, which can be laser cut to help with flexibility, is positioned sothat approximately 3 cm of the illumination fibers and the power anddata cable with CMOS camera extend distally from the tube (not shown). Aglue joint is formed at the polyimide distal end to form a bond betweenthe tube, fibers, and cable (not shown). The polyimide tube 413 extendsup to proximal end 414 where it is covered with stainless steel hypotube416 and another glue joint is applied to bond everything together. A gap418 of greater than about 2 mm is left so that tube 416 can be pusheddistally to cause deflection due to the interaction of the column andoverlying reinforcement tube or coil in the same manner as describedabove. Note, as stated above, the cover tube need not be polyimide, itcan be made of any material or other methods can be used to holdcomponents together so that they can be pushed and pulled.

Flushing liquid can be introduced through arm 420 and exits distallyfrom flush port 408 at the very distal tip which can be formed in theadhesive of epoxy using a removable PTFE covered mandrel duringmanufacturing. Flush port 408 can be 0.008″ or greater. Lock 421 is usedto lock the deflectable tip in various positions. Deflection is broughtabout by pushing and pulling tube 416, which causes the fibers and datacable to deflect the distal tip based on the column theory describedherein. A screw system can also be added to the proximal end so thatrotation will move tube 416 and bring about tip deflection. Thisparticular configuration may have a usable length L of approximately 5cm or longer. Longer versions can act as guidewire like structures,which can be tracked through an opening, like Acclarent's Relieva LumaSinus Illumination System, to provide direct visualization or to assistin placement/treatment.

In this particular embodiment, movement of the power and data cable aswell as the illumination fibers results in deflection of the distal tip.In other words, the cable and fibers can be moved proximally or distallyrelative to outer catheter 337, and thereby effect deflection in thesame manner as the axially moveable inner catheters described hereineffect deflection due to the interaction of the column 370 and outerreinforcement coil 354 (or tube).

FIG. 21C illustrates the front view of a distal tip of anotherembodiment of a coaxial bi-directional micro-endoscope 388′ without aguidewire lumen to reduce the overall outer diameter of the distal tipas well as the overall device diameter. In this embodiment, there is asingle optical fiber 411 running through the catheter body (not shown).It is embedded in glue or epoxy 410 and covered with cover 404. Thesingle fiber can be made of glass, quartz, or polymer and havedimensions of around 0.010″ to 0.020″. Alternatively, the single fibercan be a fiber optic bundle composed of many fibers or an LED. The usesof this structure can range from imaging, laser lithotripsy, or evenlighting and can be used in fields such as ENT, GI and urology.Depending on use, the proximal fittings will be required to change tofit necessary capital equipment (not shown). The above dimensions andconstruction are purely exemplary and are not limiting in any way tofinal device design. The fiber 411 can be used to deflect the tip byaxial proximal and distal movement under the column theory describedherein. The fiber diameter can range from less than 1 micron to greaterthan 600 microns.

FIG. 21D illustrates distal section 388 of FIG. 21A in partial crosssection. As shown in FIG. 21D, power and data cable 419 and fiber(s) 406run through band 415 and band 413 where they enter the outer catheter.Not shown in the partial cross section are glues, solders and markerband 404 that complete the distal tip assembly. Since glues are notshown, hole 408 which is formed in glue or adhesive 410 is not visible.Movement of power and data cables along with fibers will result in tipdeflection.

FIG. 21E illustrates FIG. 21C in a partial cross section. In thisembodiment, fiber 411 runs under band distal 419′ and proximal band 413′and then enters the outer catheter. Not shown in the partial crosssection are the glues, solder, and marker band 404 that complete the tipassembly. Movement of the fiber will result in tip deflection.

A coaxial bi-directional micro-endoscope 422, similar in construction tocoaxial bi-directional micro-endoscope 337 shown in FIGS. 20A through20C with the exception of rapid exchange port 424 is illustrated inFIGS. 22 and 23. The purpose of the rapid exchange port is to allow aguidewire or other tool to be placed through the side of the inner lumenof the catheter for tracking or treatment. The rapid exchange port maybe placed anywhere proximal of the deflecting section (D) of thecatheter. The exact placement will depend on the distal tip bendingradius used for design. In some instances, the port may be about 6 mmfrom the distal tip. Also, the length of the rapid exchange port cut onthe inner catheter (not shown) may be longer than the cut on the outercatheter to accommodate deflection with guidewire in place. However,they can also be cut to the same length or the outer can be cut longerthan the inner. Because the inner and outer catheters move relative toone another in this design, the rapid exchange ports must also be ableto move relative to one another to accommodate deflection. If theguidewire or other device will not be deflected, the rapid exchange portcan be placed in deflection section D. The provision of a rapid exchangeport can be utilized in the other embodiments of the micro-endoscopesdisclosed herein.

This particular design allows for introduction of other devices throughthe proximal end of the device. Shown extending from RHV 426 is anelectrohydraulic lithotripsy (EHL) device 428, as made by NorthgateTechnologies, Inc. (Illinois). Other possible devices for insertion mayinclude biopsy probes or guidewires, for example. Additional lighting inthe form of fibers or LEDs may also be introduced through the innerlumen so as to help in illumination during camera use. A guidewire mayalso be combined with lighting so as to provide a tracking device inaddition to lighting, as done by Acclarent in the Relieva Luma SinusIllumination System. The rapid exchange version need not have an openlumen on the proximal end of the catheter, as shown. If desired, thedesign can be close ended and lithotripsy or other treatment option maybe built into the catheter.

Lithotripsy wires (probes) 430 are embedded in the catheter distal tip.Also shown in the tip are the CMOS camera 432, illumination fibers 434,and inner catheter 436 containing guidewire 440. The components arecovered by cover 442 and then glued in place using glue or epoxy 444. Asstated early, the cover can be made out of plastic, metal or constructedusing other standard methods for containing and manufacturing endoscopeand catheter tips.

FIG. 24A illustrates an alternate embodiment of the distal tipdeflection mechanism 446. The design is meant to allow the inner shaftwith attached components to rotate and deflect 360 degrees. This isachieved by attaching the column 462 only to the inner catheter and notattaching it to the outer catheter and thus the column does not attachboth catheters. A portion L1 of the outer catheter 448, the outer coil450, and cover 452 have been removed to show internal construction. Asin earlier designs, the CMOS camera 454 and illumination fibers 456 runto the distal end 458 of the inner catheter 460 where they are mounted(glue or epoxy not shown). Although shown flush at the distal end, thefibers, camera, and catheter distal end can be staggered. In some cases,the camera may be mounted distal of the distal inner catheter tip whilethe fibers or other lighting method is proximal. Also, the innercatheter 460 is shown with a spiral tip however, as in other designs,the inner catheter can be a solid shaft. In that case, the shaft mayhave a lubricious inner liner, coil reinforcement and a variablestiffness shaft design. Column 462 is attached to distal marker band 464and proximal marker band 466, as in some of the previous designs;however, a section of the column continues proximally where it passesunder band 468 which would be glued in place. Attached at the proximalend of the column 462 is stop 476. This configuration will allow thecolumn 462 to turn with the inner catheter body and attached componentswhen it is torqued. If this design is used in combination with rapidexchange, the inner and outer exchange ports may become misaligned dueto torquing. The reinforcement (support) tube and cover have beenremoved in FIG. 24A for clarity.

FIG. 24B illustrates the tip deflection mechanism 446 with outercatheter 448, distal outer (reinforcement) coil 450 and cover 452 inplace and in use. The inner catheter 460 can be rotated causing thecolumn 462, which is now part of the inner catheter 460, to rotate whichallows 360 degree deflection because it can deflect in any plane. Whenthe outer catheter 448 is advanced, or the inner catheter 460 retracted,the other catheter 448 will make contact with end 472 and furthermovement will cause the tip to deflect. If the outer catheter 448 ispulled proximally or the inner catheter 460 is advanced, stop 476contacts the outer catheter 448 and continued movement will cause thecatheter to deflect in the opposite direction.

FIG. 25 shows a coaxial bi-directional micro-endoscope 388 without aguidewire lumen and fitted with rotational control system 474.Rotational control system 474 consists of stainless steel hypotube 476,which has been flattened in a region to create distal stop 478 andproximal stop 480, and ovalized or flattened hypotube 482, which in turnis soldered to stainless steel hypotube 484 which is dimensioned to fitinside tube 488. Glue 486 is used to lock the assembly in place insidetube 490.

In use, stainless steel hypotube 476 will be allowed to move axially todeflect the distal tip in accordance with the column/reinforcement tubestructures described herein. Hypotube 476 moves axially distally andproximally until stops 478 and 480 are reached. Rotation of hypotube 476will be restricted due to flattened region and ovalized hypotube 482through which it freely moves. The rotational control concept can beused on designs without a guidewire lumen (as shown here), designs witha guidewire lumen (rapid exchange or other), or in any design thatrequires pure axial movement with little to no rotation. In addition,although this design uses flattened hypotubes, the concept can beinjection molded into parts such as rotation hemostasis valves (RHV) toquicken manufacturing.

FIG. 26 illustrates an embodiment of a coaxial bi-directionalmicro-endoscope direct visualization system 492 using fiber opticillumination. Visualization system 490 includes coaxial bi-directionalmicro-endoscope 494 with illumination cable 496 and power and data cable498, interface board (controller) 500, and light source 502. Theillumination cable 496 is plugged into light source 502 which in turn isplugged into electrical plug 504. The light source can be fitted withLED lighting or other light source used for illuminating endoscopeillumination fibers. Also, light source may be battery powered. Thepower and data cable 498 is plugged into interface board 500, which isthen plugged into a computer 506 or other video imaging system with USBcord 508. The computer is loaded with the visualization software.

Although the interface board (controller) and light source are shown asseparate units, they can be combined into a single unit that can beplugged into the computer or optionally made wireless box using aninternal WIFI connection (board). Also, the light source can be fittedwith a foot pedal or handle to allow for increasing or decreasing lightsource intensity, which would be normally controlled at the light sourcebox, with press of pedal or button. The light source in other designsmay also be incorporated into the catheter as part of the handle, makingit disposable.

Once the visualization system is ready, a guidewire 493 is insertedthrough the working channel of coaxial bi-directional micro-endoscope494 and the combined assembly is inserted into the working channel of alarger endoscope for tracking to the area of interest inside the body.Alternatively, the micro-endoscope can be tracked over a guidewire thatis already in place in the body using either the rapid exchange or fullinner lumen version.

Once the micro-endoscope is in place, images can be viewed and recorded.If needed, the working channel of the micro-endoscope can be used fordiagnostic and/or therapeutic procedures once the guidewire is removed.When the end cap on the outer catheter's RI-IV is open, movement of theinner catheter body will result in deflection. Irrigation and/orinsufflation can be introduced through the side arm on the outercatheter RHV. After the procedure is completed, the device is removedand the coaxial bi-directional micro-endoscope 494 can be discarded orin alternate embodiments resterilized. The interface board, light sourceor combined WIFI system can be reusable.

Although interface board 500 is shown connected to a computer 506 usingUSB connector and cable 508, other connectors and formats can be used,for instance NTSC or PAL to connect to other viewing options so long asthey have the appropriate software. In addition, an IPad, IPhone (cellphone), or other device may be used for viewing if the catheter systemis configured with WIFI. The steps described above for preparation anduse of the coaxial bi-direction micro-endoscope are only an example ofhow the scope can be prepared and used. They are not meant to be thestandard. For instance, the guidewire may be optionally left out iftracking is not required of the device or the coaxial bi-directionalmicro-endoscope can be used as a standalone device not requiring anotherendoscope.

FIG. 27 illustrates a distal portion of a coaxial micro-endoscope 510fitted with distal balloon 512, such as an angioplasty balloon. Thecatheter is non-deflectable and the camera and lighting 514 are seatedproximal to the balloon. Inflation ports 516 are used for inflation ofthe balloon. Alternatively, the camera and lighting can be placed distalof the balloon, if needed, in which case they would be mounted on theinner shaft or between distal and proximal balloons. The catheter designcan be over-the-wire, rapid exchange, or non-over-the wire, depending onneed. Hydrophilic coatings may be added to help with tracking.

FIG. 28 illustrates a distal portion of a coaxial micro-endoscope 518with a pre-formed distal portion 520. Forming can be done using steam inthe operating room, as done in interventional neuroradiology or atmanufacturing facility. Pre-shaped devices may be useful in parts of thebody where a short device is used, allowing easy rotation of thecatheter for a 360 degree view. Placing a stiff wire through the centerlumen can change the angle 522 of the pre-formed tip by straighteningthe tip out. If desired, a rapid exchange port can be cut in the side ofthe catheter and coatings can be added. Lastly, catheters up to now havebeen fitted with a single, forward facing camera. It is understood thatcameras can be mounted at different angles or directions on the shaftand stereo cameras, as produced by Awaiba (Germany) may be used.

Note the dimensions and ranges provided herein are given by way example,it being understood that other dimensions and ranges for the componentsdescribed herein are also contemplated.

The deflection of the micro-endoscope of the present invention can besummarized as follows. Bi-directional deflection of the distal tip ofthe micro-endoscope can be broken down into two distinct motions: axialpull deflection and axial push deflection. Axial pull deflection can bemodeled as an eccentrically loaded column while axial push deflectioncan be modeled as an eccentrically loaded beam.

With respect to axial pull deflection, when no lateral support tube ispresent on the distal end of the micro-endoscope, the rectangularnitinol wire (or alternate column member structure such as a roddiscussed above) is modeled as an unsupported eccentrically loadedcolumn. This means that when the inner catheter is moved axiallyproximal with a force P in the proximal direction, the distal end of thecolumn (rectangular nitinol wire) will want to move axially toward itsproximal end, resulting in compression (buckling) of the nitinol wire.This is shown in FIG. 6C which illustrates movement of the column 121 inthe absence of the lateral support tube to explain the tip concept ofthe present invention. With the lateral support tube (e.g., coil)provided and the inner catheter is again pulled axially with a force Pin the proximal direction, the column (e.g., rectangular nitinol wire)will attempt to compress (buckle) axially however it will be restrictedby the lateral reinforcement tube, e.g., tube 125. Since the tip can nolonger fail axially (in compression), it will fail laterally (deflect)(see FIGS. 6D and 6E).

It should be appreciated that axial proximal movement of the innercatheter is discussed. However, it should be appreciated that distalmovement of the outer catheter would achieve the same effect. Therefore,as used herein, relative movement includes movement of the innercatheter with respect to the outer catheter, movement of the outercatheter with respect to the inner catheter, or movement of both inopposite directions with respect to each other.

With respect to axial push deflection, when no lateral support tube ispresent on the distal end of the micro-endoscope, the rectangularnitinol wire (or alternate column member structure such as a roddiscussed above) is modeled as an eccentrically loaded beam. This meansthat when the inner shaft is pushed axially with a force P it will applya moment to the end of the beam (rectangular nitinol wire), which causesit to bend (see FIG. 6F). When the lateral support tube (e.g., coil) isprovided and the inner catheter is pushed axially with a force P in thedistal direction, there will be a moment applied to the overall tipcausing it to bend (deflect) as shown in FIG. 6G and FIG. 6H. In thiscase, the addition of the coil does not change the action, it simplykeeps the components together. It should be appreciated that axialdistal movement of the inner catheter is discussed. However, it shouldbe appreciated that proximal movement of the outer catheter wouldachieve the same effect. Therefore, as used herein, relative movementincludes movement of the inner catheter with respect to the outercatheter, movement of the outer catheter with respect to the innercatheter, or movement of both in opposite directions with respect theeach other.

Axial pushing and pulling can be considered in terms of an x-y axis.Axial pushing and pulling will happen on the x axis and bending(deflection) will end up in at a point (x,y). So for compression ofcolumn causing the tip to bend to the y1 position, the distal end of thetip is traveling in the −x1 direction towards its proximal end (−x2).

Thus, as can be appreciated, in the coaxial catheter arrangement of thepresent invention, deflection of the distal tip is achieved by an axialmotion, rather than a pulling down on the distal tip as in prior artnon-coaxial catheters. Thus, the micro-endoscope itself is being used tobend the distal tip as opposed to the prior art side by side wire andcatheter. Viewed in another way, the bending is achieved not by pullingin the direction of bending but by an axial movement. The structure ofthe coaxial bi-directional micro-endoscope of the present inventionsaves space to reduce the overall size (diameter) of the micro-endoscopeto provide a reduced profile for insertion. It also provides space forfluid flow to enhance deflection (by enhancing relative movement of theinner and outer catheters) without requiring an increase in the size(diameter) of the micro-endoscope. As explained above, the coaxialbi-directional micro-endoscope can be used with the CMOS sensortechnology or with other visualized systems. It is also contemplatedthat the CMOS sensor or other visualization-system can be mounted on theinner shaft.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

What is the claimed is:
 1. A deflectable endoscope comprising: an outermember having a proximal portion, a distal portion and a first lumen; aninner member positioned within the first lumen of the outer member, theinner member having a second lumen and a distal tip portion, the innermember extending distally of the outer member; and an imaging structureattached to the distal tip portion of the inner member, at least aportion of the imaging structure attached to an outer surface of theouter wall of the inner member and radially offset of the inner member;wherein axial movement of one of the inner member or outer member withrespect to the other member while the inner member remains distal of theouter member causes the distal tip portion to deflect laterally withrespect to a longitudinal axis of the endoscope, the distal tip portiondeflectable in first and second opposing directions from a longitudinalaxis of the endoscope; wherein the second lumen terminates in a distalopening at a distalmost end of the inner member.
 2. The deflectableendoscope of claim 1, wherein the second lumen is dimensioned to receivea guidewire.
 3. The deflectable endoscope of claim 2, wherein movementof the inner member in a first axial direction deflects the distal tipportion in a first direction and movement of the inner member in asecond opposite axial direction deflects the distal tip portion in asecond different direction.
 4. The deflectable endoscope of claim 2,wherein movement of the outer member in a first axial direction deflectsthe distal tip portion in a first direction and movement of the outermember in a second opposite axial direction deflects the distal tipportion in a second different direction.
 5. The deflectable endoscope ofclaim 1, wherein the inner member is lockable in an axial position withrespect to the outer member.
 6. The deflectable endoscope of claim 5,wherein the outer member includes a rotating hemostatic valve, androtation of a cap on the rotating hemostatic valve locks the innermember in the axial position within the outer member.
 7. The deflectableendoscope of claim 1, further comprising a marker band on the innermember.
 8. The deflectable endoscope of claim 1, wherein the imagingstructure is a complementary metal-oxide-semiconductor, the imagingstructure mounted parallel to the distal tip portion of the inner memberand extending distal of the distal portion of the inner member.
 9. Thedeflectable endoscope of claim 1, wherein cables of the imagingstructure are positioned external of the outer member, the cablesextending proximally from the imaging structure of the distal tipportion.
 10. The deflectable endoscope of claim 1, wherein the imagingstructure is a complementary metal-oxide-semiconductor, the imagingstructure mounted perpendicular to the distal tip portion and extendingdistal of the distal portion of the inner member.
 11. The deflectableendoscope of claim 1, further comprising optical illumination fibers forlighting positioned within the endoscope.
 12. The deflectable endoscopeof claim 11, wherein cables of the imaging structure are positionedexternal the inner member.
 13. The deflectable endoscope of claim 1,wherein the distal tip portion normally extends linearly along thelongitudinal axis of the endoscope.
 14. A deflectable endoscopecomprising: an outer member having a proximal portion, a distal portionand a first lumen; an inner member extending through the first lumen ofthe outer member, the inner member having a distal tip portion having alongitudinally extending outer wall, the inner member extending distallyof the outer member; and an imaging structure attached to an outersurface of the outer wall of the inner member and radially offset of theinner member and distal of the outer member; wherein axial movement ofone of the inner member or outer member with respect to the other membercauses the distal tip portion of inner member to deflect laterally, theimaging structure deflecting with deflection of the distal tip portion;the distal tip portion deflectable in first and second opposingdirections from a longitudinal axis of the endoscope; wherein the innermember has a lumen terminates in a distal opening at a distalmost end ofthe inner member.
 15. The deflectable endoscope of claim 14, wherein thelumen of the inner member is dimensioned to receive a guidewire.
 16. Thedeflectable endoscope of claim 14, wherein the first lumen of the outermember is lubricated to facilitate movement of the inner member therein.17. The deflectable endoscope of claim 14, further comprising a lockingassembly to lock an axial position of the inner member with respect tothe outer member.
 18. The deflectable endoscope of claim 14, whereintransmission members of the imaging structure extend external of theouter member.
 19. The deflectable endoscope of claim 14, whereintransmission members of an illumination structure extend external of theinner member.